Multi-lumen stent-graft and related surgical methods

ABSTRACT

A multi-lumen stent-graft including a graft portion and a stent frame. The stent-graft includes multiple through-channels formed of the graft portion. The graft portion can comprise a PTFE material and the through-channels can be formed of fused portions of the graft portion. The stent-graft can be used in a prostheses that connects multiple vessel branches such as for the repair of aortic aneurysms or other vessels of the body.

INCORPORATION BY REFERENCE

Any and all applications for which a foreign or domestic priority claimis identified in the Application Data Sheet as filed with the presentapplication are hereby incorporated by reference in their entirety.

BACKGROUND Field

This disclosure generally relates to stent-grafts and related methodsand techniques for implantation within a human or animal body for therepair of damaged vessels, ducts or other passageways.

Related Art

The vessels and ducts within a human or animal body, such as bloodvessels, may occasionally weaken or increase in diameter and caneventually rupture. An example of this is an aortic aneurysm thatincludes an abnormal dilation of the wall of the aorta. Over time andexposure to the pressure of hemodynamic forces, an aneurysm can ruptureand cause fatal hemorrhaging. One surgical intervention for an aneurysmor other weakened or ruptured vessel includes the use of an endoluminalprosthesis such as a graft to provide some or all the functionality ofthe original healthy vessel and particularly to reduce hemodynamicforces on the aneurysm. U.S. Patent Pub. 2014/0371836, provides examplesof apparatus and surgical techniques for bridging an aneurysm within thethoracic aorta.

SUMMARY

According to a first aspect, a multi-lumen expandable stent-graftincluding a graft sleeve of a single tube of polymer material that formsfirst, second and third parallel flow channels between a first open endand a second open end. A self-expanding wire stent is coaxially mountedover the graft sleeve and affixed to said graft sleeve at the first andsecond open ends. The first flow channel is formed by a first linearconnected segment of the polymer material channel. The first linearconnected segment aligns parallel with a longitudinal axis of thestent-graft and includes inlet and outlet ports spaced inwardly from thefirst and second open ends of the graft sleeve. The second flow channelis formed by a second linear connected segment of the polymer materialchannel. The second linear connected segment aligns parallel with thelongitudinal axis of the stent-graft and includes inlet and outlet portsspaced inwardly from the first and second open ends of the graft sleeve.The third flow channel is formed by a third linear connected segment ofthe polymer material channel. The third linear connected segment alignsparallel with the longitudinal axis of the stent-graft, and includesinlet and outlet ports spaced inwardly from the first and second openends of the graft sleeve. The polymer material of the graft sleeve is orincludes Polytetrafluoroethylene (PTFE) and the first, second, and thirdlinear connected segments comprise fused portions of the PTFE material.A total circumference of each of the flow channels and any connectingsegments is approximately equal to a circumference of the single tube ofpolymer material.

According to a second aspect, a multi-lumen expandable stent-graftincludes a graft sleeve with polymer material forming first, second andthird flow channels between a first open end and a second open end. Aself-expanding wire stent coaxially mounts over the graft sleeve andaffixes to said graft sleeve at the first and second open ends. Thefirst flow channel is formed by a first linear connected segment of thepolymer material channel. The first linear connected segment is alignedparallel with a longitudinal axis of the stent-graft and includes inletand outlet ports spaced inwardly from the first and second open ends ofthe graft sleeve. The second flow channel is formed by a second linearconnected segment of the polymer material channel. The second linearconnected segment is aligned parallel with the longitudinal axis of thestent-graft and includes inlet and outlet ports spaced inwardly from thefirst and second open ends of the graft sleeve. The third flow channelis formed by a third linear connected segment of the polymer materialchannel. The third linear connected segment is aligned parallel with thelongitudinal axis of the stent-graft and includes inlet and outlet portsspaced inwardly from the first and second open ends of the graft sleeve.

According to another aspect, the first, second, and third channels areparallel. According to another aspect, the first, second, and third flowchannels are unsupported by the self-expanding wire stent. According toanother aspect, the first and second open ends each include acylindrical wall portion supported by the self-expanding wire stent.According to another aspect, respective ends of the first, second, andthird linear connected segments are spaced inwardly from the first andsecond open ends. According to another aspect, the first and second openends include folded portions of the polymer material. According toanother aspect, the first and second open ends include an additionallayer of the polymer material that encapsulates first and second ends ofthe stent portion. According to another aspect, the graft sleevecomprises a single tube of the polymer material and a totalcircumference of each of the flow channels is equal to a circumferenceof the single tube of polymer material. According to another aspect, thepolymer material of the graft sleeve comprises Polytetrafluoroethylene(PTFE) and the first, second, and third linear connected segmentscomprise fused portions of the PTFE material. According to anotheraspect, the fused portions of the PTFE material are formed by meltingthe PTFE material above a melting temperature thereof. According toanother aspect, the fused portions of the PTFE material are formed byultrasonic welding. According to another aspect, the fused portions ofthe first linear connected segment include an intermediate layer of PTFEmaterial. According to another aspect, the first open end has a lengththat is between 2 and 5 times greater than a length of the second openend. According to another aspect, a channel length of the first, second,and third channels is between 50% and 90% of a hub length extending froman upper rim of the first open end to a lower rim of the second openend. According to another aspect, a channel length of the first, second,and third channels is between 75% and 90% of a hub length extending froman upper rim of the first open end to a lower rim of the second openend. According to another aspect, a first diameter of the first flowchannel is within 10% to 40% of a sleeve diameter of the first andsecond open ends, a second diameter of the second flow channel is within10% to 40% of the sleeve diameter, and a third diameter of the thirdflow channel is within 50% to 80% of the sleeve diameter. According toanother aspect, a first diameter of the first flow channel is within 5%to 25% of a sleeve diameter of the first and second open ends, a seconddiameter of the second flow channel is within 5% to 25% of the sleevediameter, a third diameter of the third flow channel is within 5% to 25%of the sleeve diameter and a fourth diameter of a fourth flow channel iswithin 50% to 75% of the sleeve diameter.

According to a third aspect, an expandable stent-graft includes a graftsleeve having Polytetrafluoroethylene (PTFE) material forming a mainfluid flow channel between a first open end and a second open end ofsaid graft sleeve and including an external surface and an internalsurface. A first internal channel and a second internal channel areformed within the graft sleeve and each include inlet and outlet portsspaced inwardly from the first and second open ends of the graft sleeve.The first and second internal flow channels are separated by a linearconnected segment aligned along a longitudinal axis of the graft sleeve.The linear connected segment is formed of fused portions of the internalsurface of the PTFE material of the graft sleeve. A self-expanding wirestent is coaxially mounted over the graft sleeve and affixed to saidgraft sleeve at the first and second open ends.

According to another aspect, the first and second internal flow channelsare unsupported by the self-expanding wire stent. According to anotheraspect, the first and second open ends each include a cylindrical wallportion supported by the self-expanding wire stent. The inlet and outletports are spaced inwardly from the respective cylindrical wall portion.According to another aspect, first and second ends of the linearconnected segment are spaced inwardly from respective cylindrical wallportions of the graft sleeve. According to another aspect, thecylindrical wall portions include folded portions of the PTFE material.According to another aspect, the graft sleeve comprises a single tube ofPTFE material and a total circumference of each of the flow channels isequal to a circumference of the single tube of polymer material.According to another aspect, the fused portions of the internal surfaceof the PTFE material are formed by melting the PTFE material above amelting temperature thereof. According to another aspect, the fusedportions of the internal surface of the PTFE material are formed byultrasonic welding. According to another aspect, the first and secondchannels each comprise cylindrical wall portions. According to anotheraspect, a channel length of the first and second channels is between 50%and 90% of a hub length extending from an upper rim of the first openend to a lower rim of the second open end. According to another aspect,a channel length of the first and second channels is between 75% and 90%of a hub length extending from an upper rim of the first open end to alower rim of the second open end. According to another aspect, a firstdiameter of the first flow channel is within 20% to 50% of a sleevediameter of the first and second open ends and a second diameter of thesecond flow channel is within 50% to 80% of the sleeve diameter.

According to a fourth aspect, a method of making an expandablestent-graft includes positioning a graft sleeve includingPolytetrafluoroethylene (PTFE) material over a body of a mandrel. Themandrel includes a central portion including a first channel mandrel anda second channel mandrel. Longitudinal axes of the first and secondchannel mandrels align with a longitudinal axis of the mandrel. A firstportion of a first side of the graft sleeve is inserted between thefirst and second channel mandrels and pushed into contact with a secondportion of a second side of the graft sleeve. The first and secondportions of the graft sleeve are fused to form a linear connectedsegment aligned along the longitudinal axis of the mandrel. The linearconnected segment divides a central portion of the graft sleeve into afirst internal channel and a second internal channel formed within thegraft sleeve. The graft sleeve can be removed from the mandrel.

According to a further aspect, a self-expanding wire stent is coaxiallymounted over the graft sleeve while still on the mandrel. Theself-expanding wire stent is affixed with the first and second open endsof the graft sleeve. According to another aspect, an end portion of thegraft sleeve is folded over an end portion of the self-expanding wirestent. According to another aspect, an end portion of the self-expandingwire stent is encapsulating between an additional PTFE material and thegraft sleeve. According to another aspect, the linear connected segmentis formed by melting the PTFE material above a melting temperaturethereof. According to another aspect, the linear connected segment isformed by ultrasonic welding. According to another aspect, the first andsecond channel mandrels are detachable from the body of the mandrel.According to another aspect, the first and second channel mandrels eachcomprise a cylindrical member having a diameter corresponding to adiameter of the respective first and second channels. According toanother aspect, an intermediate layer of PTFE material is includedbetween the first portion of the first side of the graft sleeve and thesecond portion of the second side of the graft sleeve to form the linearconnected segment.

According to a fifth aspect, a method of surgically implanting aprostheses for treatment of a branched vessel includes positioning afirst stent-graft hub having a primary flow channel. A first flowchannel and a second flow channel are proximate a treatment location. Ahub guide wire is inserted within the branched vessel. A catheter isadvanced along the hub guide wire. A first stent-graft hub is deployedusing the catheter. The treatment location along the branched vessel isbridged with a primary graft tube, including advancing a primarycatheter within the primary flow channel. A first end of the primarygraft tube is deployed within the primary flow channel. A second end ofthe primary graft tube is deployed within the branched vessel with theprimary catheter. The treatment location is bridged between the firststent-graft hub and a first branch of the branched vessel with a firstgraft tube. This includes inserting a first guide wire through the firstbranch of the branched vessel and into the first flow channel of thefirst stent-graft hub, advancing a first catheter along the first guidewire, deploying a first end of the first graft tube within the firstflow channel, and deploying a second end of the first graft tube withinthe first branch with the first catheter. The treatment location isbridged between the first stent-graft hub and a second branch of thebranched vessel with a second graft tube. This includes inserting asecond guide wire through the second branch of the branched vessel andinto the second flow channel of the second stent-graft hub, advancing asecond catheter along the second guide wire, and deploying a first endof the second graft tube within the second flow channel and a second endof the second graft tube within the second branch with the secondcatheter.

According to another aspect, further including bridging the treatmentlocation between the first stent-graft hub and a third branch of thebranched vessel with a third graft tube, including inserting a thirdguide wire through the third branch of the branched vessel and into athird flow channel of the first stent-graft hub, and advancing a thirdcatheter along the third guide wire, and deploying a first end of athird graft tube within the third flow channel and a second end of thethird graft tube within the third branch. According to another aspect,further including positioning a second stent-graft hub having a primaryflow channel and a first flow channel on an opposite side of thetreatment location from the first stent-graft hub. Bridging thetreatment location along the branched vessel with the primary graft tubeby deploying the second end of the primary graft tube within the primaryflow channel of the second stent-graft hub. According to another aspect,further including bridging the treatment location between the secondstent-graft hub and a third branch of the branched vessel with a thirdgraft tube, by inserting a third guide wire through the third branch ofthe branched vessel and into the first flow channel of the secondstent-graft hub, advancing a third catheter along the third guide wire,and deploying a first end of a third graft tube within the first flowchannel of the second stent-graft hub and a second end of the thirdgraft tube within the third branch.

According to sixth aspect, a multi-lumen expandable stent-graft has agraft sleeve formed of a single tube of polymer material having a sleevediameter. A first open end includes first cylindrical wall having anupper rim. A second open end includes a second cylindrical wall having alower rim. The first open end is spaced apart from the second open endalong a longitudinal axis. A hub length extends from the upper rim ofthe first open end to the lower rim of the second open end. A pluralityof parallel flow channels extends between the first open end and thesecond open end and defines a channel length therebetween. The channellength is between 50% and 90% of the hub length. A first flow channel isformed by a first linear connected segment of the polymer materialchannel and includes inlet and outlet ports in communication with therespective first and second open ends of the graft sleeve. The firstlinear connected segment aligns parallel with the longitudinal axis ofthe stent-graft. The first linear connected segment includes a firstwidth. A second flow channel is formed by a second linear connectedsegment of the polymer material channel and includes inlet and outletports in communication with the respective first and second open ends ofthe graft sleeve. The second linear connected segment aligns parallelwith the longitudinal axis of the stent-graft. The second linearconnected segment includes a second width. A third flow channel isformed by a third linear connected segment of the polymer materialchannel and includes inlet and outlet ports in communication with therespective first and second open ends of the graft sleeve. The thirdlinear connected segment aligns parallel with the longitudinal axis ofthe stent-graft. The third linear connected segment having a thirdwidth. A fourth flow channel is formed by the first, second, and thirdlinear connected segments of the polymer material channel and includesinlet and outlet ports in communication with the respective first andsecond open ends of the graft sleeve. A self-expanding wire stentcoaxially mounts over the graft sleeve and affixes to said graft sleeveat the first cylindrical wall of the first open end and the secondcylindrical wall of the second open end. The polymer material of thegraft sleeve includes Polytetrafluoroethylene (PTFE) and the first,second, and third linear connected segments comprise fused portions ofthe PTFE material. A summation of 1) a circumference of each of thefirst, second, third and fourth flow channels and 2) twice the sum ofthe first, second, and third widths of the respective first, second, andthird linear connected segments is equal to a circumference of thesingle tube of polymer material. A first diameter of the first flowchannel is within 5% to 25% of the sleeve diameter, a second diameter ofthe second flow channel is within 5% to 25% of the sleeve diameter, athird diameter of the third flow channel is within 5% to 25% of thesleeve diameter, and a fourth diameter of the fourth flow channel iswithin 50% to 75% of the sleeve diameter.

The foregoing summary is illustrative only and is not intended to belimiting. Other aspects, features, and advantages of the systems,devices, and methods and/or other subject matter described in thisapplication will become apparent in the teachings set forth below. Thesummary is provided to introduce a selection of some of the concepts ofthis disclosure. The summary is not intended to identify key oressential features of any subject matter described herein

BRIEF DESCRIPTION OF THE DRAWINGS

Various examples are depicted in the accompanying drawings forillustrative purposes, and should in no way be interpreted as limitingthe scope of the examples. Various features of different disclosedexamples can be combined to form additional examples, which are part ofthis disclosure.

FIG. 1A shows a perspective view of a stent-graft including a stentportion and a graft portion;

FIG. 1B shows an end perspective view of the stent-graft;

FIG. 1C shows a first side view of the stent-graft;

FIG. 1D shows a second side view of the stent-graft;

Figure lE shows a first end view of the stent-graft;

FIG. 1F shows a second end view of the stent-graft;

FIG. 2A shows a section view taken at line 2A-2A in FIG. 1C;

FIG. 2B shows a section view taken at line 2B-2B in FIG. 1C;

FIG. 2C shows a section view taken at line 2C-2C in FIG. 1F;

FIG. 3A shows a side view of the stent portion of the stent-graft;

FIG. 3B shows an end view of the stent portion of the stent-graft;

FIG. 4A shows an optional configuration for multiple flow channelsincluding a main channel and three branch channels within the graftportion of the stent-graft;

FIG. 4B shows an optional configuration for multiple flow channelsincluding a main channel and two branch channels within the graftportion of the stent-graft;

FIG. 4C shows an optional configuration for multiple flow channelsincluding a main channel and one branch channels within the graftportion of the stent-graft;

FIG. 4D shows an optional configuration for multiple flow channelsincluding two main channels of equal diameter within the graft portionof the stent-graft;

FIG. 4E shows a side view of the graft portion in FIG. 4A;

FIG. 4F shows a side view of the graft portion in FIG. 4B;

FIG. 4G shows a side view of the graft portion in FIG. 4C;

FIG. 4H shows a side view of the graft portion in FIG. 4D;

FIG. 5 shows a front perspective view of another example of astent-graft;

FIG. 6 shows a rear perspective view of the stent-graft of FIG. 5 ;

FIG. 7 shows an exploded view of a mandrel assembly used in the assemblyand manufacture of a stent-graft;

FIG. 8 shows a perspective view of an end cap of the mandrel assembly;

FIG. 9 shows assembly of a tubular graft portion over the mandrel;

FIG. 10 shows formation of individual flow channels within the stentportion of the stent-graft formed by melting portions of the material ofthe graft portion between adjacent channel mandrels in the mandrelassembly;

FIG. 11 shows a section view taken along the line 11-11 in FIG. 10 ;

FIG. 12 shows alignment of the stent portion with the graft portion;

FIG. 13 shows folding of the graft portion over the open ends of thestent portion assembled over the graft portion;

FIG. 14 shows the finished stent-graft;

FIG. 15 shows insertion of a catheter into an aorta to bridge an aorticaneurysm;

FIG. 16 shows deployment of a stent-graft hub from the catheter withinthe aorta;

FIG. 17 shows insertion of a first connecting stent-graft from a firstbranch artery to within a channel of the stent-graft hub;

FIG. 18 shows deployment of the first connecting stent-graft within thechannel of the stent-graft hub;

FIG. 19 shows deployment of a prostheses within the aorta to bridge theaortic aneurysm including multiple connecting stent-graft coupled withinthe stent-graft hub;

FIG. 20 shows an alternative prostheses;

FIG. 21 shows a prostheses integrated with a heart valve;

FIG. 22 shows an alternative prostheses including two stent-grafts forbridging an aortic aneurysm;

FIG. 23 shows the prostheses of FIG. 22 further showing a bridging,connecting stent-graft;

FIGS. 24A-B show front and side views of an alternative stent-graftincluding one extended-length open end;

FIGS. 25A-C show deployment of a prostheses within the aorta to bridgean aortic aneurysm including multiple connecting stent-graft coupledwithin the stent-graft hub of FIG. 24 ;

FIG. 26 shows a perspective view of an alternative stent-graft formed ofwoven Dacron;

FIG. 27 shows a top view of the stent-graft of FIG. 26 ;

FIG. 28 shows a perspective view of an additional channel for thestent-graft of FIG. 26 ;

FIG. 29 shows the additional channel assembled with the stent-graft ofFIG. 26 .

DETAILED DESCRIPTION

The various features and advantages of the systems, devices, and methodsof the technology described herein will become more fully apparent fromthe following description of the examples illustrated in the figures.These examples are intended to illustrate the principles of thisdisclosure, and this disclosure should not be limited to merely theillustrated examples. The features of the illustrated examples can bemodified, combined, removed, and/or substituted as will be apparent tothose of ordinary skill in the art upon consideration of the principlesdisclosed herein.

Blood vessels may occasionally develop aneurysms, which can rupture andcause fatal hemorrhaging. Accordingly, it has become common practice tobridge damaged vessel segment, such as aneurysm, using a sufficientlylong graft secured within the vessel. This bridge can have the effect ofreducing hemodynamic forces on the vessel. Depending on the location ofthe aneurysm, the implantation of the bridging graft can be relativelystraight-forward or difficult. Aneurysms that develop within the aorticarch have proven particularly difficult to address for various reasons.One common reason is the sheer number of variations of arterialbranching pattern of the aortic arch between people. The aortic archincludes the ascending and descending aorta and typically includes threemajor arterial branches located in close succession: the brachiocephalicartery (leading to the right subclavian artery and the right commoncarotid artery), the left common carotid artery, and the left subclavianartery. While this arterial branching pattern is the most common, thespacing and layout between the three branches varies from person toperson. Other arterial branching patterns are also fairly common: theleft carotid artery can originate from the brachiocephalic artery ratherthan the aortic arch; the left carotid artery can originate from theaortic arch at the same location as brachiocephalic artery; and the leftcarotid artery and the left subclavian artery can branch from a commontrunk connected with the aorta, etc.

Because of the arterial branching pattern variations and relativeinaccessibility of the aortic arch, traditional surgical techniques andapparatus for addressing aneurysms have produced less than satisfactoryresults. Using conventional techniques, a person's arterial branchingpattern would generally require making a custom graft or call for largeinventories of fenestrated prosthesis. For example, a fenestrated graftwould require placement of windows to align with each the patient'sbranch vessels. During surgery, each of the branches would need to beconnected to the main stent-graft using a connection graft. However, theposition of a window with respect to a branch vessel may be misalignedor offset when the stent-graft is deployed. It may also be difficult todeploy guide wires and catheters from the stent-graft into the branchvessel to enable correct positioning of the connection graft. Also, whenthe window is offset from the branch vessel, the connection graft maykink to such an extent that blood flow will not occur through it.

Accordingly, the present disclosure includes an improved stent-graft huband prostheses, improved manufacturing processes and improved surgicaltechniques that address the current inadequacies and provide improvedmedical outcomes for aortic arch an other types of surgeries.

FIGS. 1A-F show an example of a multi-lumen stent-graft 130 including agraft portion 150 and a stent portion 190. The stent portion 190 cancomprise a shape and memory alloy such as super elastic nitinol orsimilar material. Desirably, the graft portion 150 can be made of asheet of polytetrafluoroethylene (PTFE). The graft portion 150 canalternatively be made of Dacron, polyester, and/or other syntheticmaterials known to those of skill in the art. Optionally, the materialof the graft portion 150 can be generally non-stretching.

The stent-graft 130 can include a first open end 131 and a second openend 132 opposite the first open end 131. The first end 131 can have acircular shape, although this is not required. The second end 132 canhave the same shape as the first end 131, although this is not required.The stent-graft 130 can have a diameter W. The diameter W can be uniformfrom the first end 131 to the second end 132. In other implementations,the first and second ends 131, 132 can have different diameters. Thediameter W can be between approximately 10 mm and 50 mm, depending onthe application. In one example, the first end 131 can have a diameterequal to approximately 25 mm. The second end 132 can have the samediameter or a different diameter than the first end 131. The stent-graft130 can have a hub length L from the first end 131 to the second end132. The hub length L can extend from an upper rim of the first end 131to a lower rim of the second end 132. The hub length L can be betweenapproximately 1 cm and 15 cm, depending on the application.

The first end 131 can comprise a cylindrical wall 133. The cylindricalwall 133 can include one or more end portions of the stent portion 190and/or one or more portions of the graft portion 150. The graft portion150 can be attached along an inner side and/or outer side of thecylindrical wall 133. The cylindrical wall 133 can include one or morefolded portions of the graft portion 150. The graft portion 150 can beattached to itself through openings in the stent portion 190 (e.g., viaadhesive, suturing, fusing, or other techniques). The cylindrical wall133 can be supported by the stent portion 190. The cylindrical walls133, 135 can have lengths 131 a, 132 a between approximately 1 mm and 80mm, depending on the application. A cross-section shown in FIG. 2B takenalong the line 2B-2B in FIG. 2A extends through the cylindrical wall 133and shows an inner periphery of the graft portion 150. The innerperiphery of the cylindrical wall 133 can have a circular shape havingthe diameter W. Similarly, the second end 132 can include a cylindricalwall 135 having the same structure as the cylindrical wall 133, althoughthis is not required.

The graft portion 150 can include the plurality of flow channels 140that extend through the stent-graft 130. The channels 140 can providefluid flow between the first end 131 and the second end 132. Each of thechannels 140 can be sealed from the others of the channels 140. Each ofthe channels 140 can be formed of the graft portion 150. Each of thechannels 140 can include an inlet on one end of the stent-graft 130 andan outlet on an opposite end of the stent-graft 130 (e.g., either on thefirst end 131 or the second end 132). The cylindrical walls 133, 135 canoffset the inlets/outlets of the channels 140 away from terminal rims ofthe respective first and second end 131, 132. Each of the channels 140can be parallel with a longitudinal axis A of the stent-graft 130. Thechannels 140 can be unsupported by the self-expanding wire stent (i.e.,between the first and second ends 131, 132).

The channels 140 of the stent-graft 130 can include first, second,third, and fourth channels, 141-144. The stent-graft 130 can include thechannels 141-144 for creating a stent-graft hub for use in a prostheseswithin the aortic arch of a patient and facilitating bridging of ananeurysm and connection of multiple branch arteries extending from theaortic arch with the stent-graft hub. In other examples of stent-graftsmore or fewer channels can be included. The number of channels can bebased on the application, the planned prosthetic, and/or the location ofuse (e.g., aortic arch, thoracic aorta, or other).

The diameters of the channels 140 can be uniform between the inlet andthe outlet ports of each of the channels. Thus, there can be onediameter that describes each of the channels 140. The first channel 141can be a main or primary channel having a diameter 141 a. The diameter141 a can be greater than the diameters of any or all of the remainingdiameters of the channels in the plurality of channels 140. The secondchannel 142 can have a diameter 142 a. The third channel 143 can have adiameter 143 a. The fourth channel 144 can have a diameter 144 a.

Desirably, the graft portion 150 can be formed of a single sleeve ortube comprising one or more sheets of material (e.g., bonded together).The channels 140 can each be formed of the graft portion 150 alonglinear connected segments. The linear connected segments can comprisefused lines. The linear connected segments can extend parallel with alongitudinal axis A of the stent-graft 130. The linear connectedsegments can include material of the graft portion 150 that is connectedtogether (e.g., via suturing, melting/fusing, or adhesives, or othermeans) along a line. Fused lines can be formed via melting of the graftmaterial such as through heating above a melting temperature thereof orultrasonic welding. In certain implementations, the graft material ofthe graft portion 150 can comprise PTFE and the linear connectedsegments can comprise fused portions of the PTFE. Fused lines canprovided a superior connection mechanism relative to suturing oradhesives. By bonding and intermingling of the material of differentportions of the graft portion 150, the channels 140 can be formedwithout the need to introduce additional materials. This streamlines themanufacturing process and reduces the risk of foreign materials beingpresent within the vessels. Alternatively, the graft portion 150 cancomprise a woven material such as woven polyethylene terephthalate(DACRON) and the linear connected segments can comprise sutures.

In the present example, the second channel 142 can be separated from thefirst channel 141 by a linear connected segment 151 in the graft portion150. In the present example, the third channel 143 can be separated fromthe first channel 141 by a linear connected segment 152 in the graftportion 150. In the present example, the fourth channel 144 can beseparated from the first channel 141 by a linear connected segments 153in the graft portion 150. Each of the linear connected segments caninclude a width 151 a, 152 a, 153 a extended between the relevantchannel portions 140. In certain implementations, the widths 151 a, 152a, 153 a can be between 1.0 mm and 2.0 mm, or between 0.5 mm and 5 mm.

Assuming no stretching or folding or overlapping of the graft portion150 at the first and second ends 131, 132, the circumference of thesingle tube can be equal to the summation of the circumferences of thechannels 140 and twice the lengths of the widths between the channels(e.g., 151 a-153 a). Assuming the graft portion 150 and the channels 140are circular and the widths between channels are small, the summation ofthe circumferences of the channels 140 can be approximately equal to thecircumference of the single tube having circumference (e.g.: π*W=π(141a+142 a+143 a+144 a . . . ).

FIG. 2C shows a cross-section taken along the line 2C-2C in FIG. 1Fextending through the first channel 141 and the third channel 143. Thechannels 140 can extend from the first open end 131 to the second openend 132 along a channel length 145. The channel length 145 can extendparallel with the longitudinal axis and/or the axes of the channels141-144 of the channels 140. The channel length 145 can extend from thecylindrical wall 133 to the cylindrical wall 135 (e.g., the base of thecylindrical walls). Desirably, the channel length 145 can beapproximately 75% or between 50% and 90% of the hub length L. Thisarrangement can provide a compact arrangement for the multi-lumenstent-graft 130. While longer stent-grafts can too difficult to deployand/or too difficult to connect with connecting stents, as describedbelow, the compact arrangement of the stent-graft 130 can provide foruse within tight, crowded environments, such as the aortic arch. Thecompact arrangement, together with a low hub length L (e.g., between 4and 9 cm), can provide for placement of the multi-lumen stent-graft 130within multiple different positions within the aortic arch (e.g., eitherascending or descending aorta). The ratio of the channel length 145 tothe overall length L within the high ranges provided herein and shown inFIG. 2C can also provide for sufficient length (and surface area) of thechannel 140 to securely engage with the connecting stents, as describedbelow. The total surface area overlap between the connecting stents andthe channels can be directly proportional to the strength of theconnection between the connecting stents and the stent-graft 130. Inother arrangements, the channel length 145 can be 75% and 90% or between50% and 95% of the hub length L. Each of the channels 140 can extend thechannel length 145 (e.g., the channels 140 can have the same length).The channels 140 can also extend along a seal length 146. The seallength 146 can extend parallel with the longitudinal axis and/or theaxes of the channels 141-144 of the channels 140. The seal length 146can extend from an upper end to a lower end of any of the linearconnected segments 151-153. Desirably, the seal length 146 can bebetween 75% and 100% of the channel length 145. This arrangement canprovide a compact structure of the multi-lumen stent-graft 130. In otherarrangements, seal length 146 can be 75% and 90% or between 50% and 95%of the hub length L.

FIGS. 3A-B show the stent portion 190 separated from the graft portion150. The stent portion 190 can comprise a self-expanding wire structurethat can be collapsed so as to be insertable via a catheter into a bodyvessel such as artery or vein. The material of the stent portion 190 caninclude nitinol and other similar (e.g., bio-inert) materials suchmaterials. The stent portion 190 can comprise a plurality of wiresformed in a honeycomb or cross pattern according to conventionalstructures that are known for the construction of wire stents . Thestent portion 190 can include a first end 191 and a second end 192. Thestent portion 190 can be formed generally as a cylinder with a centralpassageway extending therethrough. The first end 131 can terminate in aplurality of joints and intersections of the wires forming the stentportion 190. The stent portion 190 can be coaxially mounted on the graftportion 150. The stent portion 190 can be connected with the graftportion 150 using sutures or other mechanical fasteners. The stentportion 190 can include wires formed in a diamond-shaped overlappattern.

In certain implementations the wires can comprise barbs or otherprojections that can be used to attach more securely with otherstent-grafts or portions of the vessel wall. The barbs can be extensionsof a stent portion 190. The barbs can extend longitudinally outwardlyand/or radially outwardly or inwardly of the first and/or second ends131, 132. The barbs can provide connection points with an interiorportion of a human vessel (e.g., oriented outwardly) and/or connectionpoints with connecting grafts that can be attached within thestent-graft 130 (e.g., oriented inwardly). Radiopaque materials and/ormarks can also be included on the stent-graft 130, such as attached withthe graft portion 150 or on the stent portion 190.

FIGS. 4A-H show the graft portion 150 without the stent portion 190 andhaving various arrangements 140 a-d for the channels 140 extendingtherethrough. The channels 140 can include two, three, four, five, six,or more channels. The channels 140 can be formed using linear connectedsegments in the graft portion 150 formed of a single tube. Thestent-grafts 130 having various numbers and arrangements of the channels140. In one implementations, a set of stent-grafts can be compiled fromwhich one or more stent-grafts can be selected for be use duringsurgery. The selection from the set can be based on the intended use ofthe particular stent-graft 130 (e.g., the arterial branching pattern ofa patient). Advantageously, the set reduces the need for custom-madecomponents or carrying large stocks of physiologically specificcomponents.

The relative diameters of the channels 140 a-d relative to the width Wcan be based on the number of channels. In certain examples, the channeldiameters can be according to the following chart:

Main Channel Branch channels Number of Channels (% of W) (% of W) 250-80 20-50 3 50-80 10-40 4 50-75  5-25  5+ 50-65  5-20

FIGS. 5-6 show another implementation of a stent-graft 330 including agraft portion 350 and a stent portion 390. The stent-graft 330 caninclude a first end 331 and a second end 332. The first end 331 can beenclosed with the graft portion 350 folded outwardly over an end of thestent portion 390. The graft portion 350 can include channels 340 withinlets that open to the first end 331. The second end 332 can be openbetween the graft portion 350 and the stent portion 390. As shown inFIG. 6 , the graft portion 350 can be assembled over an outer surface ofthe stent portion 390. The first end 331 includes closed end of thegraft portion 350 while the second end 332 includes openings between thechannels 340 and the stent portion 390. The outlets of the channels 340are not directly connected to the graft portion 350 and/or the stentportion 390, but are instead “floating.” Advantageously, this allowedincreased movement of the channels 340 relative to the stent portion 390and/or vessel walls.

FIGS. 7-14 illustrate an apparatus and method for manufacturing astent-graft like the stent-graft 130 described above. The apparatus caninclude a mandrel assembly 400. The mandrel assembly 400 can include endcaps 421, 422 and a plurality of channel mandrels 440. The channelmandrels 440 can include any number of members, such as members 441,442, 443, depending on the desired arrangement for a finishedstent-graft 130. The end cap 421 can include a plurality of receptaclestherein. The receptacles can include cylindrical-shaped apertures, suchas apertures 431, 432, 433. The cylindrical-shaped apertures can besized to receive one end of each of a plurality of channel mandrels 440.The end cap 421 can be a mirror image of the end cap 422. Thecylindrical-shaped apertures of the end cap 422 can receive an oppositeend of each of the plurality of channel mandrels 440. The arrangement ofthe cylindrical-shaped apertures can be selected according to thedesired arrangement of the flow channels 140 for a finished stent-graft130. Optionally, the cylindrical apertures can be connected by one ormore slits within the end caps 421, 422, as shown in FIG. 8 .

The end caps 421, 422 can have a generally cylindrical body having adiameter D. The diameter D can be equivalent to the diameter W of thestent-graft 130. The channel mandrels 440 can each include a cylindricalbody with a diameter, such as diameters D1, D2, D3. The diameters D1-D3can correspond to the desired diameters of the flow channels 140 of afinished stent-graft 130.

The channel mandrels 440 can be assembled within respective apertures ofthe end caps 421, 422, as shown in FIG. 9 . A tubular graft portion 150can be assembled over the assembled mandrel. Opposite ends of the graftportion 150 can be aligned over the end caps 421, 422. A central portionof the graft portion 150 can be aligned with the channel mandrels 440.

As shown in FIGS. 10-11 , the material of the graft portion 150 can bepushed into contact with itself around the channel mandrels 440 of themandrel assembly 400 (e.g., members 441, 442, 443, etc.). The contactingportions of the graft portion 150 can be connected together to form thelinear connected segments (e.g., segments 151, 152, 153, etc.) thatdefine the channels 140 of the hub 130. As shown in FIG. 11 on theright, the material of the graft portion 150 has been wrapped closelyaround the member 443 and sealed to itself at the linear connectedsegment 152 to form the flow channel 143. As shown in FIG. 11 on theleft, the material of the graft portion 150 has been wrapped closelyaround the member 442 and sealed to itself at the linear connectedsegment 151 to form the flow channel 142. As shown in FIG. 11 at center,the material of the graft portion 150 has been wrapped closely aroundthe member 441 and sealed to itself at the linear connected segments 151and 152 to form the flow channel 141.

The linear connected segments can define (alone or in combination) theflow channels 140 of the stent-graft 130. The linear connected segmentscan each comprise a fused line of the material of the graft portion 150.The pattern of the fused line can be a varied. In certain examples, thepattern of the fused line can be continuous or intermittent. In certainexamples, the pattern of the fused line can be straight, comprisemultiple straight lines (e.g., zig-zag) or curved (e.g., sinusoidal). Incertain examples, another material can be included in one or more of thelinear connected segments. The additional material can include anintermediate layer of PTFE, fluorinated ethylene propylene (FEP), orother material. The additional material can be placed between thecontacting portions of the graft portion 150.

The fusing can be accomplished using a heated iron 481 and/or a secondiron 482 or other backing material. The iron 481 can be inserted betweenadjacent members of the channel mandrels 440, as necessary.Alternatively, the linear connected segments can be sutured, adhered orotherwise connected. Alternatively the fused lines can be formed usingultrasonic welding with an ultrasonic welding tip.

The process can be repeated until all flow channels 140 have beenformed. In certain implementations, the graft portion 150 can be formedinto the flow channels 140 by starting with the smaller diameter members440. After completing the smaller flow channel, the largest (primary)flow channel may be completed. The largest diameter member 441 can formthe primary flow channel 141, having the largest diameter.

After forming the flow channels 140, the stent portion 190 can beassembled coaxially over the graft portion 150 while still on themandrel assembly 400, as shown in FIGS. 12-14 . The stent portion 190can be positioned over the flow channels 140. Either end of the stentportion 190 can overlap unfolded ends 133 a, 135 a of the graft portion150. After positioning, the unfolded ends 133 a, 135 a can besequentially or simultaneously folded over the ends of the stent portion190 and secured in place (e.g., via suturing, fusing, adhesives, orother). For example, the ends 133 a and/or 135 a can be melted toencapsulate the ends of the stent portion 190. As an alternative tofolding the ends of the graft portion 150, an additional sheet or sheetsof PTFE or other material can be positioned over the stent portion 190.The additional material and the ends 133 a and/or 135 a can sandwich theends of the stent portion 190. The additional material can then be fusedwith the ends 133 a and/or 135 a of the graft portion 150. In certainembodiments, the additional material can fully encapsulate the stentportion 150.

Any additional finishing steps can be completed and the finishedstent-graft 130 can be removed by disassembly of the mandrel assembly400.

FIGS. 15-19 show an example surgical method for placement of aprostheses including a stent-graft 130 into an aortic arch 1 to bridgean aneurysm 1 a. Although described in the context of an aorticaneurysm, the techniques discussed herein can be used to address varioustypes of treatment sites (e.g., thoracic aorta). Because of theplacement of the aneurysm within the aortic arch, it is likely necessaryto bridge to more than one of the branch arteries in the aortic arch. Asdiscussed above, rather than rely on a custom stent-graft, a prosthesescan be placed using one or more stent-grafts 130 in conjunction with oneor more connecting stent-grafts (e.g., connecting stent graft 522, 523,524, 525). Each of the connecting stent-grafts can be generally formedas a tube of graft material with or without a self-expanding stent. Thediameters and lengths of the connecting stent-grafts can be selectedbased on the planned placement within the prostheses. For example, theends of the connecting stent grafts may have different diameters tobetter fit within channels or branch arteries.

Although the number of stent-grafts 130 used, the number of flowchannels 140 in the stent-grafts 130, and the length of the connectingstent-grafts 522-525 can vary, these can be selected from finite set ofstent-grafts. This can facilitate and streamline planning and executionof a surgical procedure for a wide variety of prostheses. Although aparticular layout of a prostheses is described below, the features ofthe stent-graft hub 130 and the connecting stents can be adapted to anyarterial branching pattern without requiring custom-made components.

A steerable catheter and/or guide wire 501 can be advanced into theaortic arch 1. The guide wire can be inserted through an incision thatprovides access into the femoral artery and then advanced upwardly intothe aortic arch. The guide wire 501 can be advanced in relation to theaneurysms 1 a (e.g., above the aneurysm 1 a into the ascending aorta). Acatheter 503 carrying a collapsed stent-graft 130 can be advanced alongthe guide wire 501. The collapsed stent-graft 130 can be positionedrelative to the aneurysm 1 a and deployed using the catheter 503. Thestent-graft 130 can be held in-place by radial expansion of thestent-portion 190 and/or through hooks and barbs within an inner wall ofthe aortic arch 1.

As shown in FIG. 17 , a guide wire and/or a catheter 512 can be advancedthrough the brachiocephalic artery 2 (via either the right subclavianartery or the right common carotid artery) and into one of the channels140 of the stent-graft 130. A connecting stent-graft 522 can be deployedby the catheter 512. A first end of the connecting stent-graft 522 canbe disposed within the channel 140 of the stent-graft 130. A second endof the connecting stent-graft 522 can be disposed within thebrachiocephalic artery 2. The connecting stent-graft 522 can be deployedfrom the catheter 512 and radially expanded within the channel 140 ofthe stent-graft 130. The connecting stent-graft 522 can be held in-placeby radial expansion of the stent-portion thereof and/or through hooksand barbs within in an inner wall of the channel 140. The connectingstent-graft 522 can thereby provide a fluid flow path for blood flowbetween the stent-graft 130 and the brachiocephalic artery 2.

Another guide wire and/or a catheter 513 can be advanced through theleft common carotid artery 3 and into another one of the channels 140 ofthe stent-graft 130. A connecting stent-graft 523 can be deployed by thecatheter. A first end of the connecting stent-graft 523 can be disposedwithin the channel 140 of the stent-graft 130. A second end of theconnecting stent-graft 523 can be disposed within the left commoncarotid artery 3. The connecting stent-graft 523 can be deployed fromthe catheter 513 and radially expanded within the channel 140 of thestent-graft 130. The connecting stent-graft 523 can be held in-place byradial expansion of the stent-portion thereof and/or through hooks andbarbs within in an inner wall of the channel 140. The connectingstent-graft 523 can thereby provide a fluid flow path for blood flowbetween the stent-graft 130 and the left common carotid artery 3.

Another guide wire and/or a catheter 514 can be advanced through theleft subclavian artery 4 and into another one of the channels 140 of thestent-graft 130. A connecting stent-graft 524 can be deployed by thecatheter. A first end of the connecting stent-graft 524 can be disposedwithin the channel 140 of the stent-graft 130. A second end of theconnecting stent-graft 524 can be disposed within the left subclavianartery 4. The connecting stent-graft 524 can be deployed from thecatheter 514 and radially expanded within the channel 140 of thestent-graft 130. The connecting stent-graft 524 can be held in-place byradial expansion of the stent-portion thereof and/or through hooks andbarbs within in an inner wall of the channel 140. The connectingstent-graft 524 can thereby provide a fluid flow path for blood flowbetween the stent-graft 130 and the left subclavian artery 4.Alternatively, the second end of the connecting stent-graft 524 can bedisposed within the aorta 1, such as below the stent-graft 130 or withinthe descending aorta.

Another guide wire and/or a catheter, such as the guide wire 501, can beadvanced within the aortic arch and into another one of the channels 140of the stent-graft 130, such as the primary flow channel. Anotherconnecting stent-graft 525 can be deployed by the catheter. A first endof the connecting stent-graft 525 can be disposed within the channel 140of the stent-graft 130 (such as the primary channel 141). A second endof the connecting stent-graft 525 can be disposed within aorta, such aswithin the aortic arch. The connecting stent-graft 525 can be deployedfrom the catheter and radially expanded within the channel 140 of thestent-graft 130. The connecting stent-graft 525 can be held in-place byradial expansion of the stent-portion thereof and/or through hooks andbarbs within in an inner wall of the channel 140. The connectingstent-graft 525 can thereby provide a fluid flow path for blood flowbetween the stent-graft 130 and the aorta and bridge the aneurysm 1 a.

FIG. 20 shows another example prostheses including a stent-graft 130within an aortic arch 1 for bridging an aneurysm 1 a. A guide wire canbe advanced in relation to the aneurysms 1 a. A catheter carrying acollapsed stent-graft 130 can be advanced along the guide wire. Thecollapsed stent-graft 130 can be positioned relative to the aneurysm 1 aand deployed using the catheter (e.g., below the aneurysm 1 a into thedescending aorta).

A guide wire and/or a catheter can be advanced through thebrachiocephalic artery 2 (e.g., via either the right subclavian arteryor the right common carotid artery) and into one of the channels 140 ofthe stent-graft 130. A connecting stent-graft 522 can be deployed by thecatheter 512. A first end of the connecting stent-graft 522 can bedisposed within the channel 140 of the stent-graft 130. The first end ofthe connecting stent-graft can be deployed and radially expanded withinthe channel 140. A second end of the connecting stent-graft 522 can bedisposed within the brachiocephalic artery 2. The connecting stent-graft522 can thereby provide a fluid flow path for blood flow between thestent-graft 130 and the brachiocephalic artery 2.

Another guide wire and/or a catheter can be advanced through the leftcommon carotid artery 3 and into another one of the channels 140 of thestent-graft 130. A connecting stent-graft 523 can be deployed by thecatheter. A first end of the connecting stent-graft 523 can be disposedwithin the channel 140 of the stent-graft 130. The first end of theconnecting stent-graft can be deployed and radially expanded within thechannel 140. A second end of the connecting stent-graft 523 can bedisposed within the left common carotid artery 3. The connectingstent-graft 523 can thereby provide a fluid flow path for blood flowbetween the stent-graft 130 and the left common carotid artery 3.

Another guide wire and/or a catheter can be advanced through the leftsubclavian artery 4 and into another one of the channels 140 of thestent-graft 130. A connecting stent-graft 524 can be deployed by thecatheter. A first end of the connecting stent-graft 524 can be disposedwithin the channel 140 of the stent-graft 130. The first end of theconnecting stent-graft can be deployed and radially expanded within thechannel 140. A second end of the connecting stent-graft 524 can bedisposed within the left subclavian artery 4. The connecting stent-graft524 can thereby provide a fluid flow path for blood flow between thestent-graft 130 and the left subclavian artery 4.

Another guide wire and/or a catheter can be advanced within the aorticarch and through another one of the channels 140 of the stent-graft 130,such as the primary flow channel. Another connecting stent-graft 525 canbe deployed by the catheter. A first end of the connecting stent-graft525 can be disposed within aorta, such as within the aortic arch. Asecond end of the connecting stent-graft 525 can be disposed within thechannel 140 of the stent-graft 130. The second end of the connectingstent-graft can be deployed and radially expanded within the channel140. The connecting stent-graft 525 can thereby provide a fluid flowpath for blood flow between the stent-graft 130 and the aorta and bridgethe aneurysm 1 a.

FIG. 21 shows another example prostheses including a stent-graft 130within an aortic arch 1 for bridging an aneurysm 1 a. The prostheses canhave the same structure as shown above in FIG. 19 . According to thepresent example, the stent-graft 130 can be directly connected withand/or form a portion of a heart valve 510.

FIGS. 22-23 show another example prostheses including first and secondstent-grafts 130 a, 130 b within an aortic arch 1 for bridging ananeurysm 1 a. The stent-grafts 130 a, 130 b can be deployed as describedabove (e.g., one in the ascending aorta and one in the descendingaorta). The two stent-grafts 130 a, 130 b can be positioned on oppositesides of the aneurysm 1 a.

A guide wire and/or a catheter can be advanced through thebrachiocephalic artery 2 (e.g., via either the right subclavian arteryor the right common carotid artery) and into one of the channels 140 ofthe stent-graft 130 a. A connecting stent-graft 522 can be deployed bythe catheter 512. A first end of the connecting stent-graft 522 can bedisposed and expanded within the channel 140 of the stent-graft 130 a. Asecond end of the connecting stent-graft 522 can be disposed within thebrachiocephalic artery 2. The connecting stent-graft 522 can therebyprovide a fluid flow path for blood flow between the stent-graft 130 aand the brachiocephalic artery 2.

Another guide wire and/or a catheter can be advanced through the leftcommon carotid artery 3 and into another one of the channels 140 of thestent-graft 130 a. A connecting stent-graft 523 can be deployed by thecatheter. A first end of the connecting stent-graft 523 can be disposedand expanded within the channel 140 of the stent-graft 130 a. A secondend of the connecting stent-graft 523 can be disposed within the leftcommon carotid artery 3. The connecting stent-graft 523 can therebyprovide a fluid flow path for blood flow between the stent-graft 130 aand the left common carotid artery 3.

Another guide wire and/or a catheter can be advanced through the leftsubclavian artery 4 and into another one of the channels 140 of thestent-graft 130 b. A connecting stent-graft 524 can be deployed by thecatheter. A first end of the connecting stent-graft 524 can be disposedand expanded within the channel 140 of the stent-graft 130 b. A secondend of the connecting stent-graft 524 can be disposed within the leftsubclavian artery 4. The connecting stent-graft 524 can thereby providea fluid flow path for blood flow between the stent-graft 130 b and theleft subclavian artery 4.

Another guide wire and/or a catheter can be advanced within the aorticarch and through another one of the channels 140 of the stent-graft 130a and a channel 140 of the stent-graft 130 b, such as the primary flowchannel. Another connecting stent-graft 525 can be deployed by thecatheter. A first end of the connecting stent-graft 525 can be disposedand expanded within the stent-graft 130 a, such as within the channel140. A second end of the connecting stent-graft 525 can be disposed andexpanded within the channel 140 of the stent-graft 130 b. The connectingstent-graft 525 can thereby provide a fluid flow path for blood flowbetween the stent-graft 130 a and the stent-graft 130 b and bridge theaneurysm 1 a.

FIGS. 24A-B show an example of a multi-lumen stent-graft 630, like thestent-graft 130, but with the differences noted below. The stent-graft630 can including a graft portion 650 and a stent portion 690. The stentportion 690 can comprise a shape and memory alloy such as super elasticnitinol or similar material. The graft portion 650 can be made of asingle sheet or sheets of PTFE formed in a tube. The stent-graft 630 caninclude a first open end 631 and a second open end 632 opposite thefirst open end 631. The first end 631 and of the second end 632 can havea circular shape, although this is not required. The second end 632 canhave the same shape as the first end 631, although this is not required.The first and second ends 631, 632 can include a base and an upper orlower rim.

The stent-graft 630 can have a diameter W. The stent-graft 630 can havea hub length L from the first end 631 to the second end 632. The hublength L can extend from an upper rim of the first end 631 to a lowerrim of the second end 632. The hub length L can be between approximately6 cm and 65 cm, depending on the application.

The first end 631 can have a length 631 a. The length 631 a can extendfrom the base to the upper rim. The second end 632 can have a length 632a. The length 632 a can extend from the base to the lower rim. Thelengths 631 a, 632 a can be different. Desirably, the length 631 a canbe greater than the length 631 a. The length 631 a can be between 2 and5 times greater than the length 632 a. This extended length canfacilitate connection of a stent bridge deployed inside the first end631. The length 631 a can be between 40% and 70% of the hub length L.

The graft portion 650 can include a plurality of flow channels 640 thatextend through the stent-graft 630. The channels 640 can provide fluidflow between the first end 631 and the second end 632. Each of thechannels 640 can be sealed from the others of the channels 640. Each ofthe channels 640 can be formed of the graft portion 650. Each of thechannels 640 can include an inlet on one end of the stent-graft 630 andan outlet on an opposite end of the stent-graft 630 (e.g., either on thefirst end 631 or the second end 632). Cylindrical walls of the first andsecond ends 631, 632 can offset the inlets/outlets of the channels 640away from terminal rims of the respective first and second end 631, 632.Each of the channels 640 can be parallel with a longitudinal axis A ofthe stent-graft 630. The channels 640 can be unsupported by theself-expanding wire stent (i.e., between the first and second ends 631,632). The channels 640 of the stent-graft 630 can include first andsecond channels. In other examples of stent-grafts more or fewerchannels can be included. The number of channels can be based on theapplication, the planned prosthetic, and/or the location of use (e.g.,aortic arch, thoracic aorta, or other).

The channels 640 can extend from the first open end 631 to the secondopen end 632 along a channel length 645. The channel length 645 canextend parallel with the longitudinal axis and/or the axes of thechannels of the channels 640. The channel length 645 can extend from thecylindrical wall of the first end 631 to the cylindrical wall of thesecond end 632 (e.g., to the base of the cylindrical walls). Desirably,the channel length 645 can be between 40% and 70% of the hub length L orother ranges provided above.

FIGS. 25A-C shows another example prostheses including the stent-graft630 within an aortic arch 1 for bridging an aneurysm 1 a. As describedabove, a guide wire can be advanced in relation to the aneurysms 1 a. Acatheter carrying a collapsed stent-graft 630 can be advanced along theguide wire. The collapsed stent-graft 630 can be positioned relative tothe aneurysm 1 a and deployed using the catheter (e.g., above theaneurysm 1 a and/or within the descending aorta). The first end 631 ofthe stent graft 630 can be distal to the second end 632 and extendtowards the thoracic aorta.

A guide wire and/or a catheter can be advanced through any of the brancharteries 2-4 and into one of the channels 640 of the stent-graft 630through the second end 632. A connecting stent-graft 524 can be deployedby the catheter with a first end of the connecting stent-graft 524disposed within a channel 640 of the stent-graft 630. A second end ofthe connecting stent-graft 524 can be disposed within the branch artery2-4. The connecting stent-graft 524 can thereby provide a fluid flowpath for blood flow between the stent-graft 630 and the branch artery.Another guide wire and/or a catheter can be advanced within the aorticarch and through another one of the channels 640 of the stent-graft 630,such as a primary flow channel. Another connecting stent-graft 525 canbe deployed by the catheter. A first end of the connecting stent-graft525 can be disposed within aorta, such as within the aortic arch. Asecond end of the connecting stent-graft 525 can be disposed within thechannel of the channels 640. The connecting stent-graft 525 can therebyprovide a fluid flow path for blood flow between the stent-graft 630 andthe aorta and bridge the aneurysm 1 a.

Another guide wire and/or a catheter can be advanced within the aorta(e.g., from the thoracic aorta) and into the first end 631 of thestent-graft 630. A bridge stent-graft 526 can be deployed by thecatheter. The bridge stent-graft 526 can be generally formed as a tubeof graft material with or without a self-expanding stent. The diametersand length of the bridge stent-graft 526 can be selected based on theplanned placement within the prostheses. For example, the length of thestent-graft 526 may be selected to bridge another aneurism within thedescending aorta 1. A first end of the connecting stent-graft 525 can bedisposed within the first end 631 of the stent graft 630. The first endof the connecting stent-graft 525 can be radially expanded within thefirst end 631 of the stent graft 630. The connecting stent-graft 525 canserve to elongate the first end 631. A second end of the connectingstent-graft 526 can be disposed within aorta, such as within thedescending aortic arch or into the thoracic aorta. The connectingstent-graft 526 can thereby provide a fluid flow path for blood flowbetween the stent-graft 630 and the descending aorta.

FIGS. 26-29 show an example of a multi-lumen stent-graft 730, like thestent-graft 130 but with the differences noted below. The stent-graft730 can include a graft portion 750 and a stent portion (not shown).Desirably, the graft portion 750 can be made of a sheet of woven Dacron.The stent-graft 730 can include a first open end 731 and a second openend 732 opposite the first open end 731. The graft portion 750 caninclude the plurality of flow channels 740 that extend through thestent-graft 730. The channels 740 can provide fluid flow between thefirst end 731 and the second end 732. The channels 740 can be formed ofa single tube of the woven Dacron material. Each of the channels 740 canbe separated from the others of the channels 740 by one or more suturelines 751, 752 of the Dacron material. The channels 740 of thestent-graft 730 can include first, second, and third channels, 741-743.Alternatively, other numbers of channels can be included in the channels740.

The stent-graft 730 can further include an additional channel 744. Thechannel 744 can be formed separately from the graft portion 750. Thechannel 744 can be formed by suturing, adhesive, woven material or othermeans. The channel 741 can include a first end 781 and a second end 782.The first and/or second ends 781, 782 can include excess or flaredmaterial. The first and second ends 731, 732 can include apertures 744a, 744 b within the graft portion 750. The apertures 744 a, 744 b canhave diameters corresponding to diameters of the ends 781, 782. The ends781, 782 can be attached over the apertures 744 a, 744 b to form one ofthe channels 740 extending from the first end 131 to the second end 132.The ends 781, 782 can be attached with the graft portion 750 bysuturing, adhesives and/or other mechanical means.

Certain Terminology

Terms of orientation used herein, such as “top,” “bottom,” “upper,”“lower,” “proximal,” “distal,” “longitudinal,” “lateral,” and “end,” areused in the context of the illustrated example. However, the presentdisclosure should not be limited to the illustrated orientation. Indeed,other orientations are possible and are within the scope of thisdisclosure. Terms relating to circular shapes as used herein, such asdiameter or radius, should be understood not to require perfect circularstructures, but rather should be applied to any suitable structure witha cross-sectional region that can be measured from side-to-side. Termsrelating to shapes generally, such as “circular,” “cylindrical,”“semi-circular,” or “semi-cylindrical” or any related or similar terms,are not required to conform strictly to the mathematical definitions ofcircles or cylinders or other structures, but can encompass structuresthat are reasonably close approximations.

Conditional language, such as “can,” “could,” “might,” or “may,” unlessspecifically stated otherwise, or otherwise understood within thecontext as used, is generally intended to convey that certain examplesinclude or do not include, certain features, elements, and/or steps.Thus, such conditional language is not generally intended to imply thatfeatures, elements, and/or steps are in any way required for one or moreexamples.

Conjunctive language, such as the phrase “at least one of X, Y, and Z,”unless specifically stated otherwise, is otherwise understood with thecontext as used in general to convey that an item, term, etc. may beeither X, Y, or Z. Thus, such conjunctive language is not generallyintended to imply that certain examples require the presence of at leastone of X, at least one of Y, and at least one of Z.

The terms “approximately,” “about,” and “substantially” as used hereinrepresent an amount close to the stated amount that still performs adesired function or achieves a desired result. For example, in someexamples, as the context may dictate, the terms “approximately,”“about,” and “substantially,” may refer to an amount that is within lessthan or equal to 10% of the stated amount. The term “generally” as usedherein represents a value, amount, or characteristic that predominantlyincludes or tends toward a particular value, amount, or characteristic.As an example, in certain examples, as the context may dictate, the term“generally parallel” can refer to something that departs from exactlyparallel by less than or equal to 20 degrees. All ranges are inclusiveof endpoints. Summary

Several illustrative examples of stent-grafts and related surgeries havebeen disclosed. Although this disclosure has been described in terms ofcertain illustrative examples and uses, other examples and other uses,including examples and uses which do not provide all of the features andadvantages set forth herein, are also within the scope of thisdisclosure. Components, elements, features, acts, or steps can bearranged or performed differently than described and components,elements, features, acts, or steps can be combined, merged, added, orleft out in various examples. All possible combinations andsubcombinations of elements and components described herein are intendedto be included in this disclosure. No single feature or group offeatures is necessary or indispensable.

Certain features that are described in this disclosure in the context ofseparate implementations can also be implemented in combination in asingle implementation. Conversely, various features that are describedin the context of a single implementation also can be implemented inmultiple implementations separately or in any suitable subcombination.Moreover, although features may be described above as acting in certaincombinations, one or more features from a claimed combination can insome cases be excised from the combination, and the combination may beclaimed as a subcombination or variation of a subcombination.

Any portion of any of the steps, processes, structures, and/or devicesdisclosed or illustrated in one example in this disclosure can becombined or used with (or instead of) any other portion of any of thesteps, processes, structures, and/or devices disclosed or illustrated ina different example or flowchart. The examples described herein are notintended to be discrete and separate from each other. Combinations,variations, and some implementations of the disclosed features arewithin the scope of this disclosure.

While operations may be depicted in the drawings or described in thespecification in a particular order, such operations need not beperformed in the particular order shown or in sequential order, or thatall operations be performed, to achieve desirable results.

Other operations that are not depicted or described can be incorporatedin the example methods and processes. For example, one or moreadditional operations can be performed before, after, simultaneously, orbetween any of the described operations. Additionally, the operationsmay be rearranged or reordered in some implementations. Also, theseparation of various components in the implementations described aboveshould not be understood as requiring such separation in allimplementations, and it should be understood that the describedcomponents and systems can generally be integrated together in a singleproduct or packaged into multiple products. Additionally, someimplementations are within the scope of this disclosure.

Further, while illustrative examples have been described, any exampleshaving equivalent elements, modifications, omissions, and/orcombinations are also within the scope of this disclosure. Moreover,although certain aspects, advantages, and novel features are describedherein, not necessarily all such advantages may be achieved inaccordance with any particular example. For example, some exampleswithin the scope of this disclosure achieve one advantage, or a group ofadvantages, as taught herein without necessarily achieving otheradvantages taught or suggested herein. Further, some examples mayachieve different advantages than those taught or suggested herein.

Some examples have been described in connection with the accompanyingdrawings. The figures are drawn and/or shown to scale, but such scaleshould not be limiting, since dimensions and proportions other than whatare shown are contemplated and are within the scope of the disclosedinvention. Distances, angles, etc. are merely illustrative and do notnecessarily bear an exact relationship to actual dimensions and layoutof the devices illustrated. Components can be added, removed, and/orrearranged. Further, the disclosure herein of any particular feature,aspect, method, property, characteristic, quality, attribute, element,or the like in connection with various examples can be used in all otherexamples set forth herein. Additionally, any methods described hereinmay be practiced using any device suitable for performing the recitedsteps.

For purposes of summarizing the disclosure, certain aspects, advantagesand features of the inventions have been described herein. Not all, orany such advantages are necessarily achieved in accordance with anyparticular example of the inventions disclosed herein. No aspects ofthis disclosure are essential or indispensable. In many examples, thedevices, systems, and methods may be configured differently thanillustrated in the figures or description herein. For example, variousfunctionalities provided by the illustrated modules can be combined,rearranged, added, or deleted. In some implementations, additional ordifferent processors or modules may perform some or all of thefunctionalities described with reference to the examples described andillustrated in the figures. Many implementation variations are possible.Any of the features, structures, steps, or processes disclosed in thisspecification can be included in any example.

In summary, various examples of stent-grafts and related methods havebeen disclosed. This disclosure extends beyond the specificallydisclosed examples to other alternative examples and/or other uses ofthe examples, as well as to certain modifications and equivalentsthereof. Moreover, this disclosure expressly contemplates that variousfeatures and aspects of the disclosed examples can be combined with, orsubstituted for, one another. Accordingly, the scope of this disclosureshould not be limited by the particular disclosed examples describedabove, but should be determined only by a fair reading of the claims.

1-18. (canceled)
 19. An expandable stent-graft comprising: a graftsleeve comprising Polytetrafluoroethylene (PTFE) material forming a mainfluid flow channel between a first open end and a second open end ofsaid graft sleeve and including an external surface and an internalsurface; a first internal channel and a second internal channel formedwithin the graft sleeve and each including inlet and outlet ports spacedinwardly from the first and second open ends of the graft sleeve; thefirst and second internal flow channels separated by a linear connectedsegment aligned along a longitudinal axis of the graft sleeve, thelinear connected segment formed of fused portions of the internalsurface of the PTFE material of the graft sleeve; a self-expanding wirestent coaxially mounted over the graft sleeve and affixed to said graftsleeve at the first and second open ends.
 20. The stent-graft of claim19, wherein a channel length of the first and second channels is between50% and 90% of a hub length extending from an upper rim of the firstopen end to a lower rim of the second open end.
 21. The stent-graft ofclaim 19, wherein a channel length of the first and second channels isbetween 75% and 90% of a hub length extending from an upper rim of thefirst open end to a lower rim of the second open end.
 22. (canceled) 23.The stent-graft of claim 19, wherein the first and second internal flowchannels are unsupported by the self-expanding wire stent.
 24. Thestent-graft of claim 19, wherein the first and second open ends eachinclude a cylindrical wall portion supported by the self-expanding wirestent, the inlet and outlet ports spaced inwardly from the respectivecylindrical wall portion.
 25. The stent-graft of claim 24, wherein firstand second ends of the linear connected segment are spaced inwardly fromrespective cylindrical wall portions of the graft sleeve.
 26. Thestent-graft of claim 24, wherein the cylindrical wall portions includefolded portions of the PTFE material.
 27. The stent-graft of claim 19,wherein the graft sleeve comprises a single tube of PTFE material and atotal circumference of each of the flow channels is equal to acircumference of the single tube of polymer material.
 28. Thestent-graft of claim 19, wherein the fused portions of the internalsurface of the PTFE material are formed by melting the PTFE materialabove a melting temperature thereof.
 29. The stent-graft of claim 19,wherein the fused portions of the internal surface of the PTFE materialare formed by ultrasonic welding. 30-43. (canceled)